Recalls / Class II
Class IID-0326-2015
Product
Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 07977, a) NDC 59762-3719-3, b) NDC 59762-3719-4.
- Brand name
- Alprazolam
- Generic name
- Alprazolam
- Active ingredient
- Alprazolam
- Route
- Oral
- NDCs
- 59762-3719, 59762-3720, 59762-3721, 59762-3722
- FDA application
- NDA018276
- Affected lot / code info
- Lot #: a) C100429, Exp 03/15, b) C120293, Exp 01/17
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Neolpharma, Inc.
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 99 Calle Jardines, Caguas, Puerto Rico 00725-3382
Distribution
- Quantity
- 12,310 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-12-17
- FDA classified
- 2014-12-24
- Posted by FDA
- 2014-12-31
- Terminated
- 2017-04-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0326-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.